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FDA 510(k)

Vantage PSI System

K-Number: K193432 · 2020-11-09

Applicant3D Systems
Decision Date2020-11-09
Product CodeOYK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vantage PSI System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K193432. The device is classified under product code OYK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vantage PSI System?

Vantage PSI System is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is 3D Systems. The 510(k) number is K193432.

When did Vantage PSI System receive FDA 510(k) clearance?

Vantage PSI System received FDA 510(k) clearance on 2020-11-09, under 510(k) number K193432.

Who is the listed applicant for Vantage PSI System?

The FDA 510(k) record lists 3D Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vantage PSI System?

The FDA product code for Vantage PSI System is OYK.

Other records listing 3D Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261826VSP System (Titanium Palatal Splint)K250711VSP Orthopedics SystemK243174Cadence Ankle PSI SystemK243173Salto Talaris Ankle PSI SystemK241326Cadence Ankle PSI SystemK241148Salto Talaris Ankle PSI System

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Related Devices (Code: OYK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243174Cadence Ankle PSI System3D Systems, Inc.K243173Salto Talaris Ankle PSI System3D Systems, Inc.K241326Cadence Ankle PSI System3D Systems, Inc.K241148Salto Talaris Ankle PSI System3D Systems, Inc.K231585Vantage PSI System3D Systems, Inc.K223326Axiom PSR SystemRestor3D

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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